Ex Parte Gravagna et al

Patent Trial and Appeal Board

Dec 21, 2016

13458573 (P.T.A.B. Dec. 21, 2016)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
13/458,573 04/27/2012 Philippe Gravagna H-SP-00051CON
(1600-70CON
4698
759050855
Covidien LP
555 Long Wharf Drive
Mail Stop 8N-1, Legal Department
New Haven, CT 06511
12/23/2016 EXAMINER
TSAY, MARSHA M
ART UNIT PAPER NUMBER
1656
NOTIFICATION DATE DELIVERY MODE
12/23/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
mail @ cdfslaw. com
SurgicalUS@covidien.com
medtronic_mitg-si_docketing@cardinal-ip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte PHILIPPE GRAVAGNA, YVES BA YON,
and SEBASTIEN LADET1
Appeal 2015-006211
Application 13/458,573
Technology Center 1600
Before ERIC B. GRIMES, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a
compound comprising a functionalized collagen covalently bonded directly
to chitosan. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm the rejections based on double patenting.
1 According to Appellants, the real party in interest is Sofradim Production
SAS. (Appeal Br. 1.)
Appeal 2015-006211
Application 13/458,573
STATEMENT OF THE CASE
Claims on Appeal
Claims 1—12 are on appeal.2 (Claims Appendix, Appeal Br. 10-11.)
Claim 1 is illustrative and reads as follows:
1. A compound comprising a functionalized collagen covalently
bonded directly to chitosan without the use of a crosslinking agent, wherein
the chitosan has a degree of acetylation from about 35 to 50% and wherein
the collagen is functionalized by oxidative cleavage.
(Id. at 10.)
Examiner’s Rejections
1. Claims 1—5 and 11 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Tardy,3 Rhee,4 and Shah,5 as evidenced by Freier.6 7(Ans.
2-5.)
2. Claims 5 and 11 stand provisionally rejected on the ground of
nonstatutory double patenting over claims 1—3, 7—12, and 14—17 of
copending Application No. 12/492,8277 (Id. at 6.)
3. Claim 5 stands provisionally rejected on the ground of nonstatutory
2 Claims 13—16 are withdrawn. Claims 1—12, to the species aldehydes, film,
are under consideration. Claims 1—5 and 11 read on the elected species.
(Final Act. 2, dated Aug. 6, 2014.)
3 Tardy et al., US 4,931,546, issued June 5, 1990 (“Tardy”).
4 Rhee et al., US 5,510,418, issued Apr. 23, 1996 (“Rhee”).
5 Shah et al., EPO 0486294 A2, published May 20, 1992 (“Shah”).
6 Freier et al., Controlling cell adhesion and degradation of chitosan films by
N-acetylation, Biomaterials 26, 5872—78 (2005) (“Freier”).
7 Application No. 12/492,827 issued as US 9,242,026 B2 on Jan. 26, 2016,
and the rejection is thus no longer provisional.
2
Appeal 2015-006211
Application 13/458,573
double patenting over claim 39 of copending Application No. 13/124,288.8
(Id. at 7.)
4. Claim 5 stands provisionally rejected on the ground of nonstatutory
double patenting over claim 22 of copending Application No. 13/124,163.9
(Id.)
DISCUSSION
Rejection No. 1: Obviousness
Issue
Whether a preponderance of evidence of record supports the
Examiner’s conclusion of obviousness under 35 U.S.C. § 103(a).
Analysis
We agree that the Examiner has established a prima facie case of
obviousness (Ans. 2—5), but find that Appellants’ arguments and evidence
are sufficient to rebut that prima facie case, for the reasons set forth below.
Appellants argue that the Ladet Declaration10 “presents evidence that
the claimed compound exhibits unexpectedly improved properties that the
prior art does not possess.” (Appeal Br. 7.) In particular, Appellants argue
that the comparative tests in the Ladet Declaration show that
the mechanical resistance (tensile strength) of a film made from
Appellants’] claimed compound (i.e., oxidized collagen and
chitosan with a [degree of acetylation] of 50%) is more than 8
times higher than that of comparative sample 1, which includes
8 Application No. 13/124,288 issued as US 9,272,073 B2 on Mar. 1, 2016,
and the rejection is thus no longer provisional.
9 Ladet, US Application No. 13/124,163, filed July 1, 2011. Patent and
Trademark Office records indicate that a Notice of Allowance was mailed
Oct. 7, 2016.
10 Affidavit/Declaration under 37 CFR § 1.132 of Sebastien Ladet, dated
June 18, 2013. (“Decl.” or “Ladet Declaration”.)
3
Appeal 2015-006211
Application 13/458,573
the compounds of Tardy (i.e., oxidized collagen and a
conventional glycosaminoglycan), and is more than 16 times
higher than that of comparative sample 2 (i.e., ethylated collagen
and chitosan with a [degree of acetylation] of 50%).
{Id.)
The Examiner’s position is that the claimed compound referenced in
the Ladet Declaration used a chitosan with a specific degree of acetylation
(DA) of 50% and that “using a chitosan having the claimed DA of 50% to
form a composite material for an implantable product was already known in
the art.” (Ans. 16.) In addition, the Examiner states that comparative
sample 1 in the Ladet Declaration used hyaluronic acid as the
glycosaminoglycan, whereas Tardy’s Example 15 discloses several other
glycosaminoglycans in addition to hyaluronic acid. (Id. at 16—17; see Tardy
col. 7,11. 30—37.) Furthermore, the Examiner states that the higher
mechanical resistance of the claimed compound “would not be unexpected
because Tardy [] already disclose[s] that a collagen functionalized by
oxidative cleavage for cross-linking has improved stability and mechanical
characteristics.” (Id. at 17; see Tardy col. 1,11. 11—12.)
It is well settled that “when unexpected results are used as evidence of
nonobviousness, the results must be shown to be unexpected compared with
the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed.
Cir. 1991). Moreover, while mere improvement in properties does not
always suffice to show unexpected results, “when an applicant demonstrates
substantially improved results . . . and states that the results were
unexpected, this should suffice to establish unexpected results in the absence
of evidence to the contrary.” In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995).
4
Appeal 2015-006211
Application 13/458,573
In the present case, we find the Ladet Declaration to reflect a
reasonable comparison of the claimed invention to the closest prior art
(Tardy), and that substantially improved mechanical resistance is reflected in
the test results.11 (Decl. 112.) Moreover, we are not persuaded by the
Examiner’s position that “using a chitosan having the claimed DA of 50% to
form a composite material for an implantable product was already known in
the art” (Ans. 16) because that statement appears to merely restate the
existence of a prima facie case of obviousness. Similarly, we do not agree
with the Examiner that Tardy’s reference to improved mechanical
characteristics shows that the Appellants’ test results were not unexpected.
Rather, we find that Tardy’s statement regarding “improved stability and
mechanical characteristics” does not necessarily include any improvement,
and does not specifically address mechanical resistance (tensile strength).
(See Reply Br. 7.) Thus, on this record, we find substantially improved
results in comparison to the closest prior art, a statement by Appellants that
the results are unexpected, and a lack of persuasive evidence rebutting the
showing that the results were unexpected. See Soni, 54 F.3d at 751.
Conclusion of Law
A preponderance of evidence of record fails to support the Examiner’s
conclusion of obviousness under 35 U.S.C. § 103(a).
11 A summary of the comparative test is illustrated in Graph 1 of the Ladet
Declaration, but the units for mechanical resistance in Graph 1 (Y axis) are
not legible. (Decl. 112.) Moreover, we make no determination whether the
results are more than 8 or 16 times higher than the comparative samples as
alleged by Appellants, but merely find that the results reflect substantially
improved mechanical resistance relative to the comparative samples.
5
Appeal 2015-006211
Application 13/458,573
Rejection Nos. 2—4: Nonstatutory Double Patenting
Appellants present no arguments in response to Rejection Nos. 2-4.
Accordingly, those rejections are affirmed. See 37 C.F.R. § 41.37(c)(l)(iv);
Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008).
SUMMARY
We reverse the rejection of claims 1—5 and 11 under 35 U.S.C.
§ 103(a).
We affirm the rejections of claims 5 and 11 on the ground of
nonstatutory double patenting.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
6